[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100210617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder","EXPERIMENTAL","15 patients will first receive the capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder (5mg\u002FKg) for 24 weeks. After 24 weeks of washout period they will receive capsule containing placebo (Starch) for 24 weeks.",[13,14],"Dietary Supplement: Alga Dunaliella Bardawil powder","Dietary Supplement: Placebo:Starch",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo (Starch)","PLACEBO_COMPARATOR","The other 15 Patients will receive first the placebo (Starch) capsules for 24 weeks. After 24 weeks of washout period they will receive capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder .",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Alga Dunaliella Bardawil powder","9 cis beta carotene rich Alga Dunaliella Bardawil powder",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo:Starch","Starch powder",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Ygal Rotenstreich, MD","Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","972-3-5302880","Ygal.Rotenstreich@sheba.health.gov.il",[42],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Goldschleger Eye Research Institute, Sheba Medical Center,","Tel Litwinsky","52621","Israel","IL",{"type":49,"coordinates":50},"Point",[51,52],34.84588,32.05096,{"lat":52,"lon":51},[55],{"name":33,"role":38,"phone":56,"phoneExt":26,"email":57},"972-3-530-2880","ygal.rotenstreich@sheba.health.gov.il",{"type":35,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr. Ygal Rotenstreich","Director, Electrophysiology Clinic, Goldschleger Eye Research Institute","100210617","phase-1-the-effect-of-oral-administration-of-9-cis-rich-powder-of-the-alga-dunaliella-bardawil-on-visual-functions-in-adolescent-patients-with-retinitis-pigmentosa-100210617",false,"NCT02018692","The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa","The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa","Inclusion Criteria:\n\n* Written informed consent to participate in the study.\n* Adolescent 12-18 years old.\n* Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa\n\nExclusion Criteria:\n\n* Currently a smoker\n* Current use of vitamin A\u002F β-carotene supplements\n* Active arterial disease within 3 months prior to enrolment in the study, e.g. unstable angina, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass graft surgery\n* History of malignancy, excepting basal or squamous cell skin carcinoma\n* Females who are pregnant, or breast feeding, or are premenopausal but not using chemical or mechanical contraception\n* Uncontrolled hypertension, defined either as resting diastolic blood pressure \\>95 mmHg (taken from the mean of 3 readings) or as resting systolic blood pressure \\>180 mmHg\n* History of alcohol abuse or drug abuse or both\n* Intention to engage in vigorous exercise or an aggressive diet regimen\n* Uncontrolled endocrine or metabolic disease\n* Participation in another investigational drug study within 4 weeks prior to enrolment\n* Serious or unstable medical or psychological condition which, in the opinion of the PI, would compromise the subject's safety or successful participation in the study\n* Initiation of hormone replacement therapy or oral contraceptive therapy within 3 months prior to enrolment","ALL","12 Years","18 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE1","PHASE2","The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is effective in the treatment of retinitis pigmentosa in adolescent patients.",[80],"Retinitis Pigmentosa","NOT_YET_RECRUITING","2025-09-30",{"date":84,"type":85},"2025-10-06","ACTUAL",{"date":87,"type":73},"2026-03-01",{"date":89,"type":73},"2028-12-31",{"name":5,"class":6},1]